2011-24893. Endocrine Disruptor Screening Program; Weight-of-Evidence Guidance Document; Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA's Endocrine Disruptor Screening Program (EDSP) is announcing the availability of a final guidance document titled, “Weight-of-Evidence: Evaluating Results of EDSP Tier 1 Screening to Identify the Need for Tier 2 Testing.” This weight-of-evidence (WoE) guidance document was revised based on public and peer review comments and existing peer-reviewed EPA guidelines. This guidance document provides basic principles and criteria for application of a WoE approach to evaluate results from the battery of Tier 1 screening assays along with other scientific and technical information relevant to Tier 1 screening to determine whether or not a chemical has the potential to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal pathways of the endocrine system. The combined results and information will also be used to identify which tests and information may be needed for Tier 2 testing.

FOR FURTHER INFORMATION CONTACT:

For technical information contact: Don Bergfelt, Office of Science Coordination and Policy (7203M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; e-mail address: [e-mail].

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

This action is directed to the public in general. You may be potentially affected by this action if you produce, manufacture, use, consume, work with, or import pesticide chemicals. To determine whether you or your business may be affected by this action, you should carefully examine section 408(p) of FFDCA, 21 U.S.C. 346a(p).

Potentially affected entities may include, but are not limited to:

• Chemical manufacturers, importers and processors (NAICS code 325), e.g., persons who manufacture, import or process chemical substances.
• Pesticide, fertilizer, and other agricultural chemical manufacturers (NAICS code 3253), e.g., persons who manufacture, import or process pesticide, fertilizer and agricultural chemicals.
• Scientific research and development services (NAICS code 5417), e.g., persons who conduct testing of chemical substances for endocrine effects.

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

B. How can I get a copy of this document and other related information?

EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPPT-2010-0877; FRL-8890-7. All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available electronically at http://www.regulations.gov,, or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading Room is [phone], and the telephone number for the OPPT Docket is [phone]. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure.

II. Overview of Revision Process

The Agency submitted a draft WoE guidance document for evaluating the results of EDSP Tier 1 screening for public review and comment as described in a Federal Register notice issued November 4, 2010 (75 FR 67963) (FRL-8849-8). Initially the commenting period was for 60 days, but was extended for an additional 30 days following a request from the chemical industry. Public comments were compiled and grouped according to the commonality among individual submissions so that they could be more readily and fully considered by EPA during revision of the WoE document. Comments were provided to the Agency from 13 different affiliations that mostly included the chemical industry as well as research organizations, and environmental and animal welfare advocates. In general, there were four main categories of comments considered relevant to the WoE guidance document that requested additional detail and clarification of the following:

1. Tier 1 battery of assays.

2. Assay endpoints.

3. Other scientifically relevant information.

4. WoE analysis.

The Agency considered specific comments within these categories and revised respective sections in the document. The Agency also considered peer review comments received from senior scientists across EPA with expertise in toxicology, reproductive physiology, and endocrinology encompassing health and ecological effects and made revisions. Also incorporated into the revised document are the fundamental principles and criteria for weighing and integrating different lines of evidence in a WoE evaluation articulated in existing peer-reviewed EPA guidelines. The Agency acknowledges the contribution that public and peer review comments have had in helping to expand the quantity and enhance the quality of guidance provided in this final version of the WoE document that will assist in evaluating the results of EDSP Tier 1 screening to identify the need for Tier 2 testing.

List of Subjects

• Environmental protection
• Endocrine disruptors
• Screening assays
• Weight-of-evidence

Dated: September 22, 2011.

Stephen A. Owens,

Assistant Administrator, Office of Chemical Safety and Pollution Prevention.